Cleft lips and palates are a birth defect that occurs once in approximately 600-800 live births in the United States. The highest prevalence rates for cleft lip and palate are reported for Asians and Native Americans, with Africans having the lowest rate. This birth defect forms in the first six to eight weeks of pregnancy when the embryo's head and face take shape. The embryo's face and head are formed by the joining of several convergent growing tissues. Sometimes, the tissues fail to meet or fuse and a gap (cleft) results.
A child born with a cleft lip and/or palate has a significant problem with forming a suction, which in turn impedes feeding the infant. The defect is noticeable and can take the form of an incomplete unilateral gap, which does not pass far beyond the lip, a complete unilateral cleft, which extends into the nose, or a bilateral complete cleft that extends upwards into both nostrils. The cleft can affect the underlying muscle and bone tissue. The deformity may continue from the lip back to the palate or from the rear of the palate forward. The cleft lip and/or palate can be remediated surgically through a series of one or more procedures over a period of several years. The program of reconstruction usually begins with closure of the lip in the early weeks/months of life, the palate repair closer to 10-12 months of age, followed by orthodontic procedures and occasional supplemental surgical interventions for appearance, speech or other related issues. These procedures are conducted over a series of years as the child grows and develops.
The surgical closure of the cleft lip can result in a size difference between the two nostrils and deformity of the nose. Typically, the nostril on the cleft side in a unilateral incomplete or complete cleft has been splayed laterally and has an abnormal shape and caliber (the nostril is typically larger). In a bilateral complete cleft lip, both sides tend to be splayed laterally and are abnormally large.
A major challenge in the reconstruction of cleft lip deformity is the characteristic nasal distortion that is present at birth. The discrepancy in the internal nostril caliber is a particularly important component of the cleft-related nasal distortion. In the unilateral cleft lip, the cleft surgeon's objective is to match the caliber of the normal non-cleft side nostril with the abnormal cleft side nostril. In the case of a bilateral cleft lip, the objective is to create complete nostril rings that are appropriately sized for the patient's nose and face.
Cleft nostril asymmetry is caused by a number of factors. The first cause is the congenital absence of an intact orbicularis oris sphincter muscle that results in the lateral splaying of the columella and cleft-side alar base in opposing directions. The orbicularis oris sphincter is the muscle that surrounds the opening of the mouth and allows the puckering of the lips and closes the mouth. The columella is the fleshy external end of the nasal septum that sits between the two nostrils. The ala refers to the cartilage that surrounds the nostrils. Each of the nostrils is defined by a cartilage structure surrounded by layers of epidermis, one on the outside and one on the inside. The opening of the nostrils is a ring of skin that has a slightly raised feature along the bottom of the nostril, which is also referred to as the ‘sill’. The second cause of nostril asymmetry is a congenital enlargement of the internal caliber of the cleft side nostril. This is seen in incomplete unilateral clefts as well. The third factor contributing to nostril asymmetry is the associated distortion in the underlying cartilage as well as the dento-maxillary (upper jaw) support structure which can reveal anything between a small step-deformity to a large alveolar ridge (gumline) cleft.
The reconstructive cleft surgeon's goal is to produce a balanced nose having nostrils that are laterally symmetric and equal in nostril caliber. Cleft surgeons are frequently confronted by older children, teenagers and young adults whose nostril size discrepancy represents a major component of their secondary deformity. These deformities may produce significant psychological and social problems, especially at a time when personal appearance, self-esteem and confidence are growing. Therefore, it is desirable to produce a set of nostrils that are equal in caliber and balanced to the eye.
The cleft surgeon first closes the cleft lip by incising tissue around the borders of the cleft and then mobilizing the skin, muscle and lining of the lip and nose together. When operating on the nose, it is common to mobilize the outer skin and the underlying mucosal lining off the alar cartilage in order to allow the cartilage to unbuckle from its previously abnormal configuration. The upper lip is generally shorter along the cleft side (measured along a cephalad-caudad orientation; that is, head-to-toe orientation). It is therefore necessary to lengthen the upper lip simultaneous to the reconstruction of the cleft-side of the nose. It is generally necessary for the surgeon to remove a portion of skin along the nostril floor, in the axis of the cleft, to facilitate appropriate repair and correct the caliber mismatch between the two nares. The nostrils are thus repositioned and re-anchored. The problem with incorrectly balancing the nostril shape and caliber is that one of the nostrils may subsequently be noticeably smaller or larger, necessitating further surgery. This is a commonly encountered problem.
Determining the equalization of the nostrils and their calibers has traditionally been performed by the surgeon visually approximating (‘eyeballing’) the sizes and shapes. In recent years, Dr. Stotland has begun to use urethral dilators in order to gauge the relative internal caliber of the non-cleft versus the cleft nostril. These instruments resemble traditional knitting needles and feature long shafts with a tapered end. The dilators are commonly used for urological procedures and are available in a variety of sizes. Typically, the dilators are not marked in circumferential diameters and are not purposefully designed for this particular use. Being able to accurately determine the difference in internal circumference of the two nares would allow the surgeon to precisely correct any measured discrepancy by removing or adding tissue, as required.
FIG. 1 is a view 100 in which a nasal reconstruction patient 102 is presented, according to the prior art. This illustrative patient has a congenital unilateral cleft lip that was closed by surgery as an infant, leaving a post-surgical lip deformity 104, a scar on the upper lip 106 and a nose 108 that has a normal non-cleft side nostril 110 and an abnormal cleft-side nostril 112. The cleft-side nostril is likewise deformed and pulled towards the cheek on the cleft side. The patient has an intubation tube 116 inserted in the mouth 118. The cleft surgeon or other authorized practitioner (not shown) is attempting to gauge the caliber of each nostril in order to aid in the planning of reconstructive surgery. The cleft surgeon is preparing to insert a typical urethral dilator 120 into the non-cleft side nostril 110 for the purpose of determining the caliber of that nostril. The tissue of the nostril is elastic and tends to form a circle around an inserted object and thereby provides a shape that has a measurable circumference that yields the caliber of the nostril.
FIG. 2 is a view 200 of the cleft surgeon (not shown) determining the gauge of the normal nostril 110, which is the non-cleft side of the nose 108 by inserting a urethral dilator 120 into that nostril, according to the prior art. The cleft surgeon now determines that this particular size of the urethral dilator 120 is correct and notes the measurement of the dilator using a caliper or some other measuring device. It may require retrieval and reinsertion of multiple dilators of different sizes until the correct size is selected. The cleft surgeon now estimates the approximate size of the abnormal, cleft-side nostril 112 and selects the appropriate urethral dilator.
FIG. 3 is a view 300 of the gauging of the caliber of the cleft side nostril 112 of a patient 102 utilizing a urethral dilator 302, according to the prior art. Once the cleft surgeon has withdrawn the urethral dilator 302, a measurement will be taken using a silk suture wrapped around the dilator and then the length of the suture is measured, thereby giving the caliber of the abnormal cleft-side nostril 112. The cleft surgeon will then note the difference between the measurements of the normal nostril 110 and the abnormal nostril 112 in order to determine how much tissue needs to be removed in order to balance and equalize the nostril calibers of the nose 108. Again, it may require retrieval and reinsertion of multiple dilators of different sizes until the correct size is selected.
The traditional methods of ‘eye balling’ the size of the nostrils and the use of dilators have produced inexact and imperfect results. In addition, these approaches have sometimes resulted in the need for future reconstructive surgery to correct the undesired results.
It is thus desirable to provide for the effective and exact sizing of the nostrils and thereby improve the accuracy and aesthetic outcome of the surgical intervention and hopefully lessen the need for future surgeries, the time/cost of those surgeries and the risks attendant with those surgeries. It is further desirable to have a system and method to measure the caliber of the nostrils before the reconstructive surgery, for determining the amount of tissue to be removed for equalization, and after the surgery, to accurately confirm the results. Moreover, is desirable for the system and method to be able to confront size differentials and provide a process for determining how much tissue needs to be removed from the abnormally sized nostril. It is also desirable to avoid the need for switching out of a plurality of loose gauges or tools that consume time and add clutter and complexity to the procedure. Likewise, it is also desirable to avoid guesses and the improvised use of instruments not intended for this purpose. This device should be applicable not only to nostril asymmetry associated with cleft lip and/or palate, but to any reconstructive challenge involving nares discrepancy such as post-traumatic, post-infectious, post-surgical, non-cleft congenital, etc.